Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)

The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU

The specific aim of this pre-post trial is to compare data regarding oral feeding, length of stay, and growth outcomes of 100 NICU infants to these same outcomes following the implementation of a developmentally supportive, infant driven feeding program with the NICU staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding program on a second sample of 100 NICU infants at Children's Memorial Hospital.

The specific research questions considered in this study are:

1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?
2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?
3. What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?
4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU staff evaluations and communications related to managing oral feedings with medically fragile infants?

Study Overview

• Status: Completed
• Conditions: Growth; Oral Feeding Outcomes; Length of NICU Stay
• Intervention / Treatment: Other: SOFFI

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Childrens Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Convenience sample of NICU infants discharged home prior to the implementation of the SOFFI will be compared to a convenience sample of NICU infants discharged home following the implementation of the SOFFI.

Description

Inclusion Criteria:

• Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample

Exclusion Criteria:

• Infants with medical diagnoses known to impact sucking and swallowing
• Infants unable to manage their oral secretions

• Infants who remain hospitalized beyond 3 months adjusted age

  • Infants who expire or are transferred to another inpatient unit or hospital/facility prior to discharge from the NICU

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-SOFFI infants; Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.
Post SOFFI infants; Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and	Other: SOFFI; NICU nursing and multidisciplinary staff were trained to use the SOFFI infant driven feeding program. A small group of learners (20) were trained as resources via a 2-day course and the entire nursing staff received training during a 1-1.5 hour training lecture during their annual competencies.; Other Names: Supporting Oral Feedings in Fragile Infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral feeding outcomes	Defined as percentage of ordered full feeding volume as ordered by NICU staff taken orally at NICU discharge and, if applicable, the number of days to take 100% of ordered feeding volume orally.	Up to 3 months
Oral Feeding Outcomes	Infant oral feeding outcomes per structured parent phone interview at home.	Up to 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth outcomes	Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge	Up to 3 months
Growth Outcomes	Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.	Up to 5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Length of stay in days in the NICU	Up to 3 months
Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI	Measured by staff surveys done prior to and at least 3 months following SOFFI training with NICU staff. Two surveys include one for Registered Nurses (RNs)and second survey for MD/Advanced Practice Nursing (APN) staff.	Up to 2 years

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (ESTIMATE): August 16, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Neonatal Intensive Care Unit (NICU); Supporting Oral Feeding in Fragile Infants (SOFFI); Infant Oral Feeding; Infant Growth; Preterm infant oral feeding; Preterm infant growth
• Other Study ID Numbers: 2009-13949 Horner